Advocacy at a Glance

Advocacy at a Glance offers you the bullet point summary of current advocacy issues associated with the goals of the Alliance for a Stronger FDA.

Everything Back To Normal? Not Really. FDA employees are working again because the shutdown is over. This is good. However, the situation is far from normal.

There is the backlog of 12 working days. It’s a lot to miss. Catching up will be difficult, especially while new work is coming in at an even faster clip because of the delays.

FDA can only spend at the FY 13 post-sequester level, far less than the amount it had to run comparable programs in FY 12 and not reflecting new responsibilities.

Nothing of any lasting value was accomplished. We hope that a new shutdown can be avoided in January, but our hopes rest on a new spirit of compromise that has yet to appear.

How does the CR Impact FDA Appropriations? The Continuing Resolution passed by Congress on Wednesday was a slimmed-down version of dozens of provisions that have circulated as possibilities over the last 4 weeks. The key sections: extend government funding through January 15, 2014; suspend the debt limit until February 7, 2014; and require income verification to qualify for premium and cost-sharing subsidies under the Affordable Care Act. Government funding under the CR is limited to what was available in FY 13 at the post-rescission, post-sequester level. For FDA, this means appropriations spending at the rate of $2.386 billion annually. This is about $120 million less than the agency spent in FY 12. That comes to $10 million per month less under the CR. Programs that were pinched or left short-handed in FY 13 will have to continue that way at least until mid-January.

How does the CR Impact FDA User Fees? With regard to user fees, we have been advised by FDA as follows:

FDA will assess and collect all user fees at the FY 2014 authorized rates during the period of the Continuing Resolution. Consistent with FDA’s FY 2013 annual appropriation, the Continuing Resolution for FY 2014 allows FDA to spend the full amount of actual fee collections – even if those actual collections exceed the spending limits in the FY 13 appropriations bill.

How does the shutdown impact FDA User Fee Goals? FDA has provided the following general statement:

FDA has received numerous inquiries about whether the government shutdown will result in missing any of the goal dates established under the various medical product user fee programs. As the agency previously indicated, during the shutdown certain user fee program work continued using carryover funds collected in FY 2013. For this reason, the agency does not, as a general matter, expect that goal dates will be missed as result of the shutdown.

For the biosimilar biological products program, for which carryover funds were not available during the shutdown, the agency plans to extend the existing goal dates by the number of days the government was shut down. Even so, because of the need to reschedule certain internal meetings or meetings with product sponsors, some biosimilars goal dates may not be met.

Sequestration: Impact Uncertain. The Continuing Resolution’s expiration was intentionally set for January 15, before sequestration cuts would be implemented later in January. Democrats generally favor a higher spending level than the CR and want to negate sequestration for at least FY 14. Republicans generally favor a lower aggregate spending level than the CR, thereby avoiding sequestration. Failing that, they would want sequestration to be imposed to bring spending down and would permit agencies greater flexibility in allocating cuts. If the current CR’s spending level were to be extended to the whole year, sequestration would require $20 billion in cuts. Under current law, all of that would come from defense and none from non-defense programs. This is explained here. Nonetheless, this is not a good outcome for FDA because both the House and Senate Agriculture appropriations bills for FY 14 would have funded FDA at levels significantly above the FY 13 post-sequester level.

Alliance to Discuss FDA Funding on BioCentury This Week Television. Steven Grossman, the Alliance for a Stronger FDA’s Deputy Executive Director, will be featured on BioCentury This Week television on Sunday to discuss the consequences of the shutdown and sequestration on FDA as well as prospects for the agency’s budget increases. The program will be broadcast in Washington on WUSA, Channel 9, at 8:30 a.m. and will be available online starting at 9:00 a.m. For more details on the program please click here.